The Long-lasting Effects of Repetitive Neck Muscle Vibrations on Postural Disturbances in Standing Position in Chronic Stroke Patients

Completed

• Conditions: Hemiplegia; Stroke
• Interventions: Other: Vibration sessions

• Registration Number: NCT03112616
• Lead Sponsor: Rennes University Hospital

Brief Summary

One of the causes of disability in patients suffering from a stroke is postural imbalance. Sensory stimulation improves the postural symmetry of the subject transitorily and they are thought to have an effect on the spatial frame of reference through a sensory recalibration. Studies have shown that sensory stimulation by vibration of neck muscles have an immediate effect on static balance and when walking. The objective of this preliminary study is to test the long-lasting effects of repetitive neck muscle vibrations on postural disturbances in standing position and on spatial frame reference in chronic patients.

Detailed Description

The hypothesis of this study is that the proprioceptive repeated stimulation by vibration of neck muscles in the long term improved postural asymmetry in connection with the egocentric representation of body disorders.

The effect of vibration simultaneously on improving postural asymmetry and on improving markers of the perception of the body in space (LBA, SSA, Subjective Visual Vertical (SVV), Rod and frame) will be assessed.

Study Timeline

• Study Start: 2016-02-15
• Study First Submitted: 2016-08-09
• Primary Completion: 2017-02-27
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Study Completion: 2017-04-18
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-16
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Adult (age ≥ 18 years) under 80 years,

• Right or left unilateral supratentorial ischemic or hemorrhagic lesion

• The first symptomatic episode

• Stroke

  • older than 12 months
  • with or without hemianopsia
  • with or without visuospatial hemineglect

• Standing balance ≥ 30 sec unaided

• Percentage of weight bearing asymmetry on the hemiplegic lower limb (on a force platform)

• Written informed consent of the patient or a member of his entourage (in the case of patients with motor difficulties)

Exclusion Criteria

• Orthopaedic, rheumatologic, neurologic, vestibular or visual disorders affecting the distribution of the centre of pressure while standing on the force platform
• Visual disorder that does not allow assessment of the spatial frame of reference test
• Difficulty with understanding protocol procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Left-brain damaged chronic patients	Vibration sessions	-
Right-brain damaged chronic patients	Vibration sessions	-

Primary Outcome Measures

Name	Time	Method
Changes from baseline Weight Bearing Asymmetry at Day 15	Before and after the intervention program (Day 15)	The primary evaluation criteria is the percentage of the Weight Bearing Asymmetry on the hemiparetic lower limb (WBA) calculated as the mean of 4 trys, each based on a 30 seconds duration with the two eyes open (OP) and then again with the two eyes closed. This evaluation is realized on a force platform.

Secondary Outcome Measures

Name	Time	Method
Change from baseline of patients' sensitivity	1 month after the end of the program	Assessment of superficial tact on the hemiplegic lower limb compared to the safe limb
Subjective Visual Vertical (SVV) test	7 days and 15 days after the start of the intervention	The effect on spatial reference frame is evaluated by Subjective Visual Vertical (SVV) test
Change from baseline of patients' motor skills	1 month after the end of the program	Assessment of motor skills with simple motor tasks
Change from baseline of patients' spasticity	1 month after the end of the program	Assessment of spasticity with Ashworth Modified scale
Haptic and visual Subjective Straight Ahead (SSA) test	7 days and 15 days after the start of the intervention	The effect on spatial reference frame evaluated by haptic and visual Subjective Straight Ahead (SSA) test
Evaluation of Longitudinal Body Axis (LBA)	7 days and 15 days after the start of the intervention	The effect on spatial reference frame is evaluated on Longitudinal Body Axis (LBA)
Rod and Frame Test	7 days and 15 days after the start of the intervention	The effect on spatial reference frame is evaluated by the Rod and Frame Test
Change from baseline of patients' functional capacity	1 month after the end of the program	Functional capacity is a composite index made of sensitivity test, motor scale and spasticity scale

Trial Locations

Locations (1)

CHU Rennes - Pontchaillou Hospital; 🇫🇷 Rennes, Brittany, France